CompletedPhase 2Results posted
miRNAs, Suicide, and Ketamine - Plasma Exosomal microRNAs as Novel Biomarkers for Suicidality and Treatment Outcome
NCT02418195 · University of Alabama at Birmingham
Closed to entry
Status
Not accepting participants
Phase 2
Phase
247
Target enrolment
1
Study sites
1 US states
What it is testing
Summary
The purpose of this study is to examine whether neural-derived exosomal miRNAs are differentially expressed that are specific to suicidal ideation or behavior, and which by affecting specific miRNA targets and pathways, are associated with suicidal behavior and response to ketamine. The following groups of subjects will be examined: 1) major depressive disorder (MDD) with a recent suicide attempt (in past 2 weeks), 2) MDD with serious ideation (in the past 7 days) without recent suicide attempt (in the past 6 months), 3) MDD without clinically significant suicidal ideation (in the past 7 days) or recent suicide attempt (in the past 6 months), and 4) healthy controls. Both suicidal and non-suicidal MDD will be given ketamine (0.5 mg/kg, IV) and blood will be drawn at predose, 30 min, 180 min, 24 hours, and 14 days post-infusion to measure changes in miRNAs.
As of May 2022, study is in data analysis. Final outcomes will be known once analysis is complete.
As of July 2022, all data collection is complete. The primary and secondary data outcome measure results are complete.
The investigators are working on final analysis of the mRNA samples, to provide final responses to questions posed in the Detailed Description section below and listed here: 1) whether suicidal ideation or behavior is associated with differences in the expression of specific miRNAs, 2) whether anti-suicidal/antidepressant effects of ketamine is associated with miRNAs changes, and 3) whether miRNA/mRNA-regulatory pathways contribute to suicide pathogenesis and treatment response.
Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.
What counts as success
Primary outcome measures
Beck Scale for Suicide Ideation (BSS)
Measured over 180 minutes post dose
A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.
Who can take part
Eligibility, as published
18 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion Criteria:
1. Age 18-65
2. Physically healthy and capable of undergoing ketamine infusion
3. Willing and able to provide informed consent
4. Diagnosis of Major Depressive Episode (MDE) as determined by the Mini International Neuropsychiatric Interview (MINI) (MDD participants)
5. Hamilton Depression Rating Scale (HAM-D) 21 score ≥ 16 (MDD participants)
6. Suicide attempt occurred within past 2 weeks (MDD Participants with Suicide Attempt)
7. For the time frame of the past 7 days, Columbia-Suicide Severity Rating Scale (C-SSRS) score ≥ 3 (MDD Participants without Suicide Attempt, with Suicidal Ideation)
8. For the time frame of the past 7 days, C-SSRS score \< 3 (MDD Participants without Suicide Attempt, without SUicidal Ideation)
Exclusion Criteria:
1. Pregnancy or lactation
2. Post-partum state (being within 2 months of delivery or miscarriage)
3. Homicide risk as determined by clinical interview
4. A lifetime history of psychotic disorder
5. Any history of dissociation or dissociative disorder
6. Bipolar disorder
7. Pervasive developmental disorder
8. Cognitive disorder
9. Cluster A personality disorder
10. Anorexia nervosa
11. Treatment with one of the following medications, known to affect the glutamate-N-methyl-D-aspartate (NMDA) receptor system (specifically: lamotrigine, acamprosate, memantine, riluzole, or lithium)
12. Alcohol or drug dependence (except nicotine and caffeine) within the last month or the use of any hallucinogen (except cannabis), including phencyclidine in the last month
13. Any known hypersensitivity or serious adverse effect associated with ketamine treatment
14. Any clinically-significant medication condition or therapy that would preclude treatment with ketamine, to include: Recent myocardial infarction
15. Unstable angina
16. Active neoplasm in the past 6 months
17. Immunosuppressive or corticosteroid therapy within the last month, with the following exceptions: any inhaled, intranasal, topical or vaginal corticosteroids are allowed.
18. Chemotherapy
19. Head injury of loss of consciousness in the past 6 months
20. If the subject reports any of the following disorders:
* Rheumatoid arthritis
* Lupus erythematosus
* Autoimmune hepatitis
* Autoimmune peripheral neuropathy
* Autoimmune pancreatitis
* Behcet's disease
* Chrohn's disease
* Autoimmune glomerulonephritis
* Grave's disease
* Guillain-Barre syndrome (if active)
* Hashimoto's thyroiditis
* Autoimmune polymyositis or polymyalgia (fibromyalgia is OK)
* Myasthenia gravis
* Narcolepsy
* Polyarteritis nodosa
* Scleroderma
* Sjogren's syndrome
* Transverse myelitis
* Wegener's granulomatosis
* HIstory of seizures (only childhood febrile seizures allowed)
* (HIV and Hepatitis are OK if stable)
21. Systolic blood pressure \> 150 and/or diastolic blood pressure \>90 at screening
22. A Corrected QT Interval (QTc) \> 480 msec as determined by an ECG
Where
1 study site
| Facility | City | Region | Country |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | United States |
On the registry
Contact the trial directly
This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.
Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.
NCT02418195 on ClinicalTrials.gov →
Last updated in the registry 2022-08-30. Registry records change; this page reflects the data build of 2026-08-25.
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